1. Field of the Invention
The invention concerns a device for sealing and drainage of a natural or artificial intestinal outlet, the device comprising an inflatable balloon with a generally toroidal structure.
2. Description of the Prior Art
U.S. Pat. No. 3,802,418 discloses a so-called colon catheter for indwelling removal of feces. The device comprises a ring-like balloon structure which is fixed on the distal end of a separate continuous trans-anal shaft element. The balloon structure is an elastic, latex like material which is distended to a ring shape by a required filling pressure. The portion of the device extending through the anus is not a part of the balloon, but a shaft element inserted into the toroidal balloon and extending through the anus to the outside. Therefore, the trans-anal and intra-rectal portion of such shaft element is sufficiently rigid in consistency to keep the drainage lumen open and withstand the lumen-collapsing effect of the elastically expanding anchoring intra-rectal balloon element. Such devices are known to cause trauma in several regards, during prolonged placement in the body. The rigid trans-anal catheter shaft typically causes mechanical irritation and ulcers of the anal mucosa. Further, its continuous anal placement causes a permanent dilation of the anal sphincter, which may influence the function of the sphincter muscle after removal of the device. The intra-rectal catheter balloon, on the other hand, often induces the formation of pressure associated ulcers in the terminal rectum, due to the pressured, solid consistency of the anchor balloon.
In U.S. Pat. No. 5,569,216 a more advanced catheter for prolonged rectal placement is shown. The anchoring intra-rectal balloon is a thin-walled elastic material. The trans-anal single-walled tube segment is elastic and expands to the required diameter during the passage of stool. It retracts to a smaller resting diameter afterwards. Due to the elastic and deformable nature of the trans-anal segment of the device, pressure and irritation related damage of the anal channel can be reduced. Further, the device is equipped with an intra-rectal occlusion function, sealing the intra-rectal portion of the drainage channel against feces and irrigation fluid. The device, though, does not grant an occlusion of the trans-anal passage way, nor can the trans-anal portion be expanded against the structures of the anal channel.
US 2004/0039348A1 is an improved continuation of U.S. Pat. No. 5,569,216, whereby the trans-anal and intra-rectal segment are each specifically defined by their material hardness, whereby the most critical segment for non-traumatic long-term placement, the trans-anal device portion, is made of a softer material, than the less soft anchoring components of the head unit. The soft and pliable trans-anal tube segment consists of a single layer of silicone typical elasticity. An active seal or opening function of the trans-anal segment is not within the scope of US 2004/0039348A1.
U.S. Pat. No. 5,545,179 (Williamson) describes a device characterized by an inverted balloon body, for use in laparoscopic procedures. The device provides a permanent gas tight seal “preventing the escape of pressurized carbon dioxide from the body cavity”. Through the collapsed inner opening of the described toroid, surgical instruments can be inserted and withdrawn, and an air-tight seal against the introduced shaft of the instrument provided. The laparoscopic device contains a seal element, which “upon inflation . . . compresses the inner channel and the passage way it defines.” The elastomeric sealing element “is preferably a unitary construction composed of an elastomeric material such as silicone”, manufactured preferably in a dipping process over a mandrel. It describes a funnel-like element at its proximal end outside the body, easing the insertion of an instrument through the tightly compressed inner channel from the outside to the inside.
The device is designed for short term usage, during the period of surgery and is removed then. It is neither compatible with the requirements of atraumatic long-term placement, nor is it designed for trans-anal drainage of feces or any other material from the inside of the abdomen to the outside of the body. The force required to inflate the sealing toroid from an elastic base figure would occlude the drainage channel, the passage of stool would be impossible. The uptake of liquid and semi-liquid feces by a funnel-like distal mouth-piece within the toroid, and the continuous flow or passage of bowel contents from the inside to the outside of the body through a completely preshaped, largely un-elastic, un-pressured balloon body is not an integral part of the former invention.
Williamson prefers a silicone elastomer. In order to reduce silicone typical friction in the open center when a surgical device is inserted or withdrawn, the inner channel of the toroid can be optionally co-molded with polyethylene or polyurethane.
U.S. Pat. No. 4,555,242 (Saudagar) describes a drainage device, which is inserted into a surgical stoma through the abdominal wall. The device shows a unique construction of the balloon, which is based on a highly compliant, silicone like elastomer with a typical elongation of 600 to 900 percent.
The elastic, partially preshaped balloon element is mounted on a flexible, but non-collapsible shaft element, granting continuous drainage of urine through the shaft lumen, when the balloon on its outside is expanded by inflation to seal pressure. The shaft element reaches from the distal device end inside the bladder cavity continuously to the proximal end outside the body wall.
The specific structural and compliance properties of the balloon shall enable a particular seal effect within the trans-abdominal channel and an anchoring function against the bladder wall. The device realizes that by a partially shaped balloon element, which is distended to its seal and anchor configuration in two distinct stages of balloon inflation. First, the tubular segment of the balloon begins to expand elastically within the trans-abdominal stoma; second, the distal bulbous end expands inside the bladder. In order to secure the initial distension of the tubular segment, its wall thickness is sufficiently thinner than in the bulbous intra-abdominal anchor segment.
The device is designed to “drain directly through a stoma, rather than through the urinary sphincter and the urethra”, for placement periods of up to two or three months. Due to its non-collapsible trans-abdominal portion it cannot be placed inside a sphincter muscle without causing tissue irritation and other sphincter trauma related to permanent dilation of the anal opening and the muscle.